THE CONCERNS OF ROSUVASTATIN CLINICAL EFFICACY AND SAFETY
https://doi.org/10.38109/2225-1685-2013-2-35-42
Abstract
In the article the authors consider some concerns of clinical efficacy and safety of rosuvastatin - the most powerful representative of the group of statins. The review contains the results of clinical trials, demonstrating its high lipid-lowering efficacy, impact on surrogate and primary endpoints in studies on primary and secondary prevention. They also discuss safety treatment concerns with this drug, and its possible side effects. The authors present data on the comparative efficacy and tolerability of generic form of rosuvastatin (Mertenil, Gedeon Richter) which had been received by Russian and foreign researchers, the evidence about the comparability of therapeutic efficacy and safety of the generic to the original form.
Keywords
About the Authors
V. V. Kukharchuk
Russian Cardiology Research Complex
Russian Federation
Russian Federation
P. P. Malyshev
Russian Cardiology Research Complex
Russian Federation
Russian Federation
References
1. Martin P.D., Warwick M.J., Dane A.L., et al. Metabolism, excretion, and pharmacokinetics of rosuvastatin in healthy adult male volunteers. Clin Ther. 2003;25:2822-2835
2. Schwartz G.G., Bolognese M.A., Tremblay B.P., et al. Efficacy and safety of rosuvastatin and atorvastatin in patients with hypercholesterolemia and a high risk of coronary heart disease: a randomized, controlled trial. Am Heart J. 2004;148(1):e4.
3. Jones P.H., Hunninghake D.B., Ferdinand K.C., et al. Effects of rosuvastatin versus atorvastatin, simvastatin, and pravastatin on non-high-density lipoprotein cholesterol, apolipoproteins, and lipid ratios in patients with hypercholesterolemia: additional results from the STELLAR trial. Clin Ther. 2004;26(9):1388-1399
4. Stein E.A., Strutt K., Southworth H., et al. Comparison of rosuvastatin versus atorvastatin in patients with heterozygous familial hypercholesterolemia. Am J Cardiol. 2003;92:1287-1293
5. Deedwania P.C., Hunninghake D.B., Bays H.E., et al. Effects of rosuvastatin, atorvastatin, simvastatin, and pravastatin on atherogenic dyslipidemia in patients with characteristics of the metabolic syndrome. Am J Cardiol. 2005;95(3):360-366
6. Ooi E.M., Watts G.F., Nestel P.J., et al. Dose-dependent regulation of high-density lipoprotein metabolism with rosuvastatin in the metabolic syndrome. J Clin Endocrinol Metab. 2008;93:430-437
7. Ai M., Otokozawa S., Asztalos B.F., et al. Effects of maximal doses of atorvastatin versus rosuvastatin on small dense low-density lipoprotein cholesterol levels. Am J Cardiol. 2008;101:315-318
8. Crouse J.R. 3rd, Raichlen J.S., Riley W.A., et al. Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial. JAMA 2007;297:1344-1353
9. Nissen S.E., Nicholls S.J., Sipahi I., et al. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA 2006;295:1556-1565
10. Ballantyne C.M., Raichlen J.S., Nicholls S.J., et al. Effect of rosuvastatin therapy on coronary artery stenoses assessed by quantitative coronary angiography: a study to evaluate the effect of rosuvastatin on intravascular ultrasound-derived coronary atheroma burden. Circulation 2008;117:2458-2466
11. Ridker P.M., Danielson E., Fonseca F.A., et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008;359(2):2195-2207
12. Kjekshus J., Apetrei E., Barrios V., et al. Rosuvastatin in older patients with systolic heart failure. N Engl J Med. 2007;357:2248-2261
13. Tavazzi L., Maggioni A.P., Marchioli R., et al. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet 2008;372:1231-1239
14. Fellstrom B.C., Jardine A.G., Schmieder R.E., et al. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009;360:1395-1407
15. Yun K.H., Jeong M.H., Oh S.K., et al. The beneficial effect of high loading dose of rosuvastatin before percutaneous coronary intervention in patients with acute coronary syndrome. Int J Cardiol. 2009;137:246-251
16. Yun K.H., Oh S.K., Rhee S.J., et al. 12-month follow-up results of high dose rosuvastatin loading before percutaneous coronary intervention in patients with acute coronary syndrome. Int J Cardiol. 2011;146:68-72
17. Shepherd J., Vidt D.G., Miller E., et al. Safety of rosuvastatin: update on 16,876 rosuvastatin-treated patients in a multinational clinical trial program. Cardiology 2007;107(4):433-443
18. Hu M., Tomlinson B. Current perspectives on rosuvastatin. Integr Blood Press Control 2013;6:15-25
19. Sattar N., Preiss D., Murray H.M., et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010;375:735-742
20. Preiss D., Seshasai S.R., Welsh P., et al. Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a meta-analysis. JAMA 2011;305:2556-2564
21. Navarese E.P., Buffon A., Andreotti F., et al. Metaanalysis of impact of different types and doses of statins on new-onset diabetes mellitus. Am J Cardiol. 2013;111(8):1123-1130
22. Ridker P.M., Pradhan A., MacFadyen J.G., et al. Cardiovascular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial. Lancet 2012;380:565-571
23. Kekes E., Csaszar A. Testing the anti-lipid properties of rosuvastatin - a non-interventional, observational clinical study (TIGER). Cardiologia Hungarica 2012;42:61-67
24. Зубарева М.Ю., Рожкова Т.А., Горнякова Н.Б. и соавт. Эффективность, безопасность и переносимость терапии розувастатином у больных очень высокого сердечно-сосудистого риска с первичной гиперхолестеринемией (предварительные результаты исследования «40х40»). Врач 2012;№12:61-65
25. Драпкина О., Палаткина Л., Зятенкова Е. Плейотропные эффекты статинов. Влияние на жёсткость сосудов. Врач 2012;№9:5-8
26. Задионченко В.С., Шехян Г.Г., Шахрай Н.Б. и соавт. Влияние розувастатина на липидный обмен, микроциркуляцию и показатели центральной гемодинамики у больных с острым коронарным синдромом. Consilium Medicum 2011;13(5):85-89
27. Гиляревский С.Р., Орлов В.А., Кузьмина И.М., Батурина О.В. Гиполипидемические эффекты применения интенсивных режимов приёма статинов при лечении больных с острым коронарным синдромом: подходы к выбору препарата и его дозы. Кардиол и сердечно-сосуд хир 2012;5(4):36-41
28. Пристром А.М., Самоходкина С.В., Крейтер М.Л., Гуменюк А.Г. Сравнительная эффективность и безопасность Мертенила® (розувастатина) у пациентов с гиперлипидемией. Медицинские новости 2013;№3:51-56
29. Саморукова Е.И., Ли В.В., Задионченко В.С. и соавт. Плейотропные эффекты розувастатина у больных хронической обструктивной болезнью лёгких. Лечащий врач 2013;№7:103-107
30. Шевченко О., Халилулин Т., Шевченко А. и соавт. Нелипидные и противовоспалительные эффекты розувастатина у реципиентов сердца. Врач 2013;№5:76-79
Review
For citations:
Kukharchuk V.V., Malyshev P.P. THE CONCERNS OF ROSUVASTATIN CLINICAL EFFICACY AND SAFETY. Eurasian heart journal. 2013;(2):35-42. (In Russ.) https://doi.org/10.38109/2225-1685-2013-2-35-42
Views:
360
Email this article 
